MalnutritionPhase 2NCT03545490
Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical
A Phase 2 study testing Early nutritional intervention in people with Malnutrition, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Malnutrition
- What is being tested?
- Early nutritional intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male or female, between 18 and 70 years old;
- Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment;
- Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months;
- Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol;
- Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study
Who cannot join
- Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician.
- Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician.
- Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician;
- Subject has diabetes
- Subject has known history of allergy or intolerance to any ingredient in the investigational product;
- Female subjects are pregnant or plan to get pregnant within a year or are postpartum and non-lactating;
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- Subject has mental illness, cannot understand ICF, unwilling to provide informed consent.
- Subject has amputation or implanted electronic devices or metal, it may be inappropriate to use BIA to measure body composition
- Subject is currently or has participated in any clinical trial 2 months prior to enrollment.
- Subject plans to take nutritional supplements and/or traditional Chinese medicine regularly during study in the opinion of study physician. Multi-vitamin and multi-mineral supplements are exception.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection
The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).
Read the detailed description
This clinical trial will be conducted in a single-center, prospective, and randomized manner. In this protocol, the standard radio(chemo)therapy duration is 6-7 weeks. Early enteral nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before post-operative radio(chemo)therapy begins and stopping this intervention when post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional supplementation was given either through the oral route (Cohort 1) or tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). Dietitians will design meal plans for both groups of subjects so that their normal diets will provide 25-30 kcal/d/kg body weight in addition to nutritional supplements.
- Conditions
- Malnutrition
- Being tested
- Early nutritional intervention
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early nutritional interventionDietary supplement
Early nutritional intervention (Ensure) was given two weeks before radiotherapy. Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-intervention | Experimental | Oral supplements are given through oral route 2 weeks before radiotherapy. Receives: Dietary Supplement: Early nutritional intervention |
| Cohort 1-Control | Active comparator | Oral supplements are given through oral route on demand during radiotherapy. Receives: Dietary Supplement: Early nutritional intervention |
| Cohort 2- Intervention | Experimental | Oral supplements are given by tube feeding 2 weeks before radiotherapy. Receives: Dietary Supplement: Early nutritional intervention |
| Cohort 2- Control | Active comparator | Oral supplements are given by tube feeding on demand during radiotherapy. Receives: Dietary Supplement: Early nutritional intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
changes of body weight from baseline to Final Visit/Exit.
Measured: 10 weeks
Secondary outcomes (20)
Body weight
Changes of body weight from baseline to V2, V3 and V4
Measured: 2weeks,5 weeks, 8 weeks
Body Mass Index
Body Mass Index variables at baseline to V2, V3,V4 and Final Visit/Exit
Measured: 10 weeks
Calf circumference by measure
Calf circumference variables at baseline to V3 and Final Visit/Exit
Measured: 5weeks, 10 weeks
Lean mass measured by Bioelectrical impedance analysis (BIA)
Lean mass variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
Fat mass measured by Bioelectrical impedance analysis (BIA)
Fat mass variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
Patient-Generated Subjective Global Assessment/PG-SGA scores
PG-SGA scores, an assessment tool for nutritional status at baseline, V3 and Final Visit/Exit.
The Scored PG-SGA includes the four patient-generated historical components (Weight History, Food Intake, Symptoms and Activities and Function), the professional part (Diagnosis, Age, Metabolic stress, and Physical Exam), the Global Assessment (A = well nourished, B = moderately malnourished or suspected malnutrition, C = severely malnourished), the total numerical score, and nutritional triage Recommendations (0-1=No intervention required, 2-3 Education and lab values as appropriate, 4-8 Required intervention, >=9 Indicates a critical need for improved and/or nutrient intervention).
Subtotal 4 historical components: scoring 0-30+
- Weight history and Symptoms scores are additive
- Food intake and Activities and Function, the highest point score,
Professional component:
- Criteria for condition, scoring 0-6
- Metabolic Stress, scoring 0-3
- Physical components, scoring 0-3
Measured: 5weeks 10 weeks
Dietary adherence and intake assessment
Dietary adherence and intake assessment will be conducted by dietitians at V2, V3, V4 and Final Visit/Exit. Dietary adherence will be determined through comparing subjects' meal plans and actual consumptions as reflected by food diaries.
Measured: 2weeks,5 weeks, 8 weeks, 10 weeks
Prealbumin by drawing blood
Prealbumin variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
Albumin by drawing blood
Albumin variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
Hemoglobin by drawing blood
Hemoglobin variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
White blood cell by drawing blood
White blood cell variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
Peripheral blood lymphocyte by drawing blood
Peripheral blood lymphocyte variables at baseline, V3 and Final Visit/Exit
Measured: 5weeks 10 weeks
Tolerability to radio(chemo)therapy assessment on treatment status
Treatment status (e.g., treatment course and doses completed as planned or changed) since last visit at V3, V4 and Final Visit/Exit
Measured: 5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on treatment change due to side effects
Number of days when treatment is suspended due to side effects since last visit at V3, V4 and Final Visit/Exit
Measured: 5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on complications
Incidence of radio(chemo)therapy-related complications such as oral mucositis, pneumonia, and shingles since last visit at V3, V4 and Final Visit/Exit
Measured: 5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications
Number of days when patients stay in hospital for treatment of radio(chemo)therapy-related complications since last visit at V3, V4 and Final Visit/Exit (if applicable)
Measured: 5 weeks, 8 weeks, 10 weeks
Quality of life assessed by Quality of Life Questionnaire-Core 36 of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-C30 questionnaire
Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-C30 questionnaire at baseline, V3, V4 and Final Visit/Exit
Measured: 5 weeks, 8 weeks, 10 weeks
Quality of life assessed by Quality of Life Questionnaire-Head and Neck 35 questionnaire of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-H&N35
Subjective assessment of physical activity, mood, fatigue and eating status by EORTC Quality of Life QLQ-H\&N35 questionnaire at baseline, V3, V4 and Final
Measured: 5 weeks, 8 weeks, 10 weeks
Health economics assessment on medications treatment due to complications
Costs for medications treated for radio(chemo)therapy-related complications during this study
Measured: 10 weeks
Radio(chemo)therapy treatment effect
The variable is local tumor control probability assessed at baseline and Final Visit/Exit.
Local tumor control probability is defined as the percentage of patients who do not have tumor recurrence in the total patients.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Jun 2017
- Primary completion31 Oct 2020
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guopei Zhu, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Guopei Zhu, Study director, Shanghai 9th people hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545490
- Sponsor's protocol ID
- ANCH 1601
- Status last verified
- Aug 2020
- First submitted
- 21 Mar 2018
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jiang W, Zhang H, Dou S, He Y, Zhu G, Li R. Effectiveness of Early Oral Nutritional Supplementation in Preventing Weight Loss in Head and Neck Cancer Patients Undergoing Postoperative Radiotherapy or Chemoradiotherapy: A Prospective Randomized Controlled Trial. J Am Nutr Assoc. 2025 Aug;44(6):498-507. doi: 10.1080/27697061.2025.2458277. Epub 2025 Feb 4.
PubMed 39903480
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Clinical Study to Evaluate the Effects of Early Enteral Nutritional Supplementation on Clinical Outcomes in Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical Resection
- ClinicalTrials.gov ID
- NCT03545490
- Acronym / sponsor ID
- ANCH 1601
- Conditions
- Malnutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The target population in the present study is Chinese patients with oral and oropharyngeal cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient department. Investigators hypothesize that early enteral nutrition intervention, which is initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added on demand during radiotherapy, will improve patients' nutritional status, tolerability to the radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of oral nutritional supplements during the course of irradiation treatment. There are two cohorts in this trial, cohort 1 included patients with oral nutritional supplements and cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy).
Detailed description
This clinical trial will be conducted in a single-center, prospective, and randomized manner. In this protocol, the standard radio(chemo)therapy duration is 6-7 weeks. Early enteral nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before post-operative radio(chemo)therapy begins and stopping this intervention when post-operative radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional supplementation was given either through the oral route (Cohort 1) or tube feeding (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). Dietitians will design meal plans for both groups of subjects so that their normal diets will provide 25-30 kcal/d/kg body weight in addition to nutritional supplements.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-intervention | Experimental | Dietary Supplement: Early nutritional interventionOral supplements are given through oral route 2 weeks before radiotherapy. |
| Cohort 1-Control | Active comparator | Dietary Supplement: Early nutritional interventionOral supplements are given through oral route on demand during radiotherapy. |
| Cohort 2- Intervention | Experimental | Dietary Supplement: Early nutritional interventionOral supplements are given by tube feeding 2 weeks before radiotherapy. |
| Cohort 2- Control | Active comparator | Dietary Supplement: Early nutritional interventionOral supplements are given by tube feeding on demand during radiotherapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is male or female, between 18 and 70 years old;
- Subject has clinical or radiological diagnosis of oral cancer (stage III and stage IV), had surgical resection 3 or 4 weeks prior to radio (chemo)therapy, and plans to receive radio (chemo)therapy treatment;
- Subject has Karnofsky Performance Score (KPS) ≥ 60 and an expected life expectancy ≥ 6 months;
- Subject is willing to comply with the study protocol, able and willing to consume study product according to the protocol;
- Subject has voluntarily signed and dated the informed consent form (ICF), approved by an Institutional Review Board (IRB) / Independent Ethics Committee (IEC) prior to any participation in the study
Key exclusion criteria (10 listed)
- Except for oral cancer and oropharyngeal cancer, subject has malignant tumors or serious infectious diseases, such as tuberculosis activity, respiratory system, cardiovascular system, urinary system diseases, systemic edema and ascites caused by diseases, etc., cannot participant in study in the opinion of study physician.
- Subject has dysfunction of liver, kidney or gallbladder, cannot participant in study in the opinion of study physician.
- Subject has gastrointestinal diseases to cannot tolerate enteral nutrition (such as intestinal bleeding, intestinal obstruction, severe digestive malabsorption, severe nausea and vomiting and diarrhea) that preclude his or her participation in the opinion of study physician;
- Subject has diabetes
- Subject has known history of allergy or intolerance to any ingredient in the investigational product;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early nutritional interventionEarly nutritional intervention (Ensure) was given two weeks before radiotherapy. Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water. | Dietary supplement | Cohort 1-Control, Cohort 1-intervention, Cohort 2- Control, Cohort 2- Intervention |
Primary outcome
Body weight
Time frame: 10 weeks
changes of body weight from baseline to Final Visit/Exit.
20 secondary outcomes
Body weight
Time frame: 2weeks,5 weeks, 8 weeks
Body Mass Index
Time frame: 10 weeks
Calf circumference by measure
Time frame: 5weeks, 10 weeks
Lean mass measured by Bioelectrical impedance analysis (BIA)
Time frame: 5weeks 10 weeks
Fat mass measured by Bioelectrical impedance analysis (BIA)
Time frame: 5weeks 10 weeks
Patient-Generated Subjective Global Assessment/PG-SGA scores
Time frame: 5weeks 10 weeks
Dietary adherence and intake assessment
Time frame: 2weeks,5 weeks, 8 weeks, 10 weeks
Prealbumin by drawing blood
Time frame: 5weeks 10 weeks
Albumin by drawing blood
Time frame: 5weeks 10 weeks
Hemoglobin by drawing blood
Time frame: 5weeks 10 weeks
White blood cell by drawing blood
Time frame: 5weeks 10 weeks
Peripheral blood lymphocyte by drawing blood
Time frame: 5weeks 10 weeks
Tolerability to radio(chemo)therapy assessment on treatment status
Time frame: 5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on treatment change due to side effects
Time frame: 5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on complications
Time frame: 5 weeks, 8 weeks, 10 weeks
Tolerability to radio(chemo)therapy assessment on staying in hospital due to complications
Time frame: 5 weeks, 8 weeks, 10 weeks
Quality of life assessed by Quality of Life Questionnaire-Core 36 of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-C30 questionnaire
Time frame: 5 weeks, 8 weeks, 10 weeks
Quality of life assessed by Quality of Life Questionnaire-Head and Neck 35 questionnaire of European Organization for Research on Treatment of Cancer/EORTC Quality of Life QLQ-H&N35
Time frame: 5 weeks, 8 weeks, 10 weeks
Health economics assessment on medications treatment due to complications
Time frame: 10 weeks
Radio(chemo)therapy treatment effect
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Derived from this study: PubMed 39903480Jiang W, Zhang H, Dou S, He Y, Zhu G, Li R. Effectiveness of Early Oral Nutritional Supplementation in Preventing Weight Loss in Head and Neck Cancer Patients Undergoing Postoperative Radiotherapy or Chemoradiotherapy: A Prospective Randomized Controlled Trial. J Am Nutr Assoc. 2025 Aug;44(6):498-507. doi: 10.1080/27697061.2025.2458277. Epub 2025 Feb 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guopei Zhu study director
Shanghai 9th people hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Early nutritional intervention in people with Malnutrition, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.